IU Center for Bioethics Reports

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Published reports generated through Center activities and research.

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    The Unfinished Business of US Drug Safety Regulation
    (Food & Drug Law Journal, 2006) Evans, Barbara J.; Flockhart, David A.
    Various proposals have been advanced in response to recent problems with the safety of Food and Drug Administration (FDA)-approved drugs. Many call for incremental change, such as new safety oversight bodies or minor expansions of FDA's existing powers. "Fixing" FDA may not fix the problem, without related reform of the broader legal framework in which FDA operates. Key reform challenges include promoting clinical compliance with important safety warnings while preserving needed flexibility for physicians to adapt drug use to the individual patient; developing a clearer distinction between pre- and postapproval safety regulation; and devising mechanisms for funding investments in safety improvements. Until these fundamental problems are addressed, the United States will face ongoing problems with drug safety and patients will be denied the full measure of safety and therapeutic benefit that today's technologies could support. This article proposes a new direction to address these problems in the context of an insurance-based framework for promoting drug safety.
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    What Will It Take to Reap the Clinical Benefits of Pharmacogenomics?
    (Food & Drug Law Journal, 2006) Evans, Barbara J.
    Genetically targeted drug and biologic therapies promise a new era of personalized medicine, but there has been frustration with how slowly these therapies are moving from concept to actual clinical application. Various legal and regulatory barriers threaten to delay translation of basic discoveries into approved products and to slow the clinical uptake of new therapeutic products as they become available. There is a pressing need to reach consensus on what these barriers are, so that they can be addressed in a timely and effective manner. This paper explores what some of the key barriers may be. It examines: (1) legal, regulatory, and commercial barriers to “successive improvement” of existing drugs through improved targeting strategies; (2) barriers to cooperative, multi-party development of targeted therapies; (3) methodological problems in assessing the incremental health and economic benefits of an improved targeting strategy; (4) limitations of traditional product labeling as a medium for communicating timely, clear information about drug targeting to clinicians and the need to create new mechanisms within the medical profession to manage and communicate this information; and (5) difficulty defining the appropriate line between regulation of medical products and regulation of medical practice, in the case of targeted therapies.
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    Relevant academic literature, applicable federal regulations for the protection of human subjects on emergency research involving artificial/substitute blood products (including PolyHeme)
    (Indiana University Center for Bioethics, 2006-03-27) Brown, Brandon
    Federal oversight of research involving human subjects is found in two regulatory regimes within the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). 21 CFR 50, 56 - the Office of Human Research Protections (OHRP), and 45 CFR 46. Generally, any research that is testing a drug, device, or other product that will be submitted for FDA approval must follow their regulations (21 CFR 50/56), while research that is supported by federal funds (e.g., an NIH grant) must also comply at a minimum with 45 CFR 46 Subpart A (the federal policy for the protection of human subjects, also known as the Common Rule), and with Subparts B,C,D as appropriate. While most of the FDA and OHRP regulations are similar (or substantially overlap), there are a number of areas in which they differ. Further, all institutions supported by federal funds must negotiate a Federalwide Assurance with OHRP that provides for all research within an institution to be subject to the Common Rule, regardless of whether the research is federally funded.
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    Diverse Perspectives: Considerations About Embryonic Stem Cell Research
    (2006-09-01T18:18:29Z) Indiana University Center for Bioethics, Stem Cell Study Group
    Since the initial isolation of human embryonic stem cells in 1998 (Thomson et al. 1998), important developments in research have offered the promise of valuable therapeutic breakthroughs while continuing to raise significant social, ethical, legal and policy challenges. Among the interests of the Indiana University Center for Bioethics (IUCB) is a desire to engage issues of this kind, and in so doing, to provide a resource to the IU community, to Indiana, and to the entire country. The topic of stem cell research was, therefore, an appropriate one for discussion at the Center. In January 2002, the IUCB created a Stem Cell Study Group (SCSG). Our primary goal was to provide a forum for informed public discussion of the issues by making use of the considerable local scientific, legal and ethical expertise. In other words, we wanted primarily to educate ourselves about these issues. Our secondary goal was to identify and describe those points on which agreement could be achieved, as well as those issues on which agreement proved difficult if not impossible. This paper summarizes our efforts to meet both of these goals.
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    Health Related Philanthropy: The Donation of the Body (And Parts Thereof)
    (2006-09-05T14:59:22Z) Indiana University Center for Bioethics, Health Related Philanthropy Study Group
    The academic study of philanthropy has focused on private action for the public good, and on the area of various determinants of giving. Yet one very obvious act of giving in the health field has been largely neglected in philanthropic studies; the literal donation of self: blood, tissue, DNA, organs and bodies. There is a long tradition in bioethics research involving the ethical, legal and policy issues associated with donation, including factors involving the donation of bodies and their parts whether for transplantation, treatment, research, or education. This report describes the main outcomes of the Study Group, specifically the results of a national telephone survey conducted on our behalf by the IUPUI Public Opinion Lab; and the publications, scholarly presentations, and related outreach efforts in the media and elsewhere.
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    International Research Ethics: A Needs Assessment of Research Ethics Capacity Final Report and Responses
    (2006-09-11T13:32:14Z) Meslin, Eric M.; Sidle, JE; Wools-Kaloustian, K; Were, E; Salmon, K; Chuani, C
    International collaborative research often raises challenging ethical issues for researchers, review committees and institutions. To date, much of the commentary and discussion surrounding these issues have focused on difficulties in interpreting guidelines, regulations, and policies and on the lack of harmonization. Efforts at regulatory reform and guideline development is one method of contributing to research ethics capacity building, but these are “top-down” approaches involving governments, regulatory agencies, and the challenge of achieving consensus. A complementary strategy is to work from the “ground up”: fashioning collaborative agreements between institutions, ethics review committees, and researchers. Working from the “ground up,” we conducted a needs assessment with participants from the Indiana University School of Medicine and the Moi University Faculty of Health Science in order to determine how best to implement a Memorandum of Understanding (MOU) developed between the two institutions. The MOU was designed to address the working relationship between the two universities with respect to their joint research activities and was the product of a Workshop convened in Eldoret, Kenya in February 2003. This work is a direct result of the MOU which explicitly states that “It is expected and intended that among the actions arising from this MOU will be the development of policies, Standard Operating Procedures and other resources that will address specific issues not mentioned here.” The interviews and focus groups provided a wealth of information about current knowledge, policies, procedures, and systems in place at MU and IU, respectively. They also provided a rich source of ideas for enhancing research ethics capacity.
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    Confronting the ethics of pandemic influenza planning: communiqué from the 2008 Summit of the States
    (Indiana University Center for Bioethics, 2008-07)
    Recognizing the vital role that public health departments play in planning for an outbreak of pandemic influenza, this “Summit of the States” was convened on July 14-15, 2008, on the campus of Indiana University-Purdue University Indianapolis (IUPUI) by the Association of State and Territorial Health Officials, the Indiana State Department of Health and the Indiana University Center for Bioethics. Invitations were extended to all 50 states, 6 territories and the District of Columbia. More than 150 delegates from 35 jurisdictions accepted, making this one of the largest gatherings of senior leadership from state and territorial public health departments ever convened to discuss the ethical issues in pandemic influenza planning.
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    Pandemic influenza preparedness: ethical issues and recommendations to the Indiana State Department of Health
    (Indiana University Center for Bioethics, 2008-08) Meslin, Eric M.; Alyea, Jennifer M.; Helft, Paul R.
    In August of 2007, the Indiana University Center for Bioethics (IUCB) presented to the Indiana State Department of Health (ISDH) a set of technical advisory documents (TADs) addressing ethical issues that may arise in the event of an influenza pandemic. The topics of altered standards of care, triage, vaccine allocation, and healthcare workforce management all were addressed in these documents, each with its own annotated bibliography. Additionally, IUCB provided to ISDH an ethical framework entitled Points to Consider, which consisted of a set of seven ethical points that the Center believed the State should take into consideration when developing policies and procedures related to pandemic influenza response. Since that time, ethicists, researchers, and policymakers have continued to contribute to the literature and develop policies addressing ethical pandemic influenza planning. As a result, ISDH again contracted with IUCB to update the previous documents with the most current thinking on the respective topics.
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    Report from the pandemic influenza project: expert panel meetings
    (2008-08-27T17:03:37Z) Gaffney, Margaret M.; Carr, Katherine A.
    The Indiana University Center for Bioethics convened expert panels for each of the four topics of the Technical Advisory Documents (TADs): altered standards of care, triage, vaccine and antiviral allocation, and healthcare workforce management. The goal of each meeting was to assess the relevance and applicability of the recommendations put forth by the TADs. Participants were encouraged to apply the seven ethical points and assess the feasibility of the recommendations by examining case studies intended to portray real world ethical dilemmas. Engagement from the public was critical for each panel to learn the full ethical and social implications of pandemic influenza preparedness and planning.
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